Nanoscale Encryption: The Solution to Counterfeit Drugs?

In one of the buildings of the sprawling Illinois Science & Technology Park in Skokie, Illinois, tucked away in his black briefcase, are the drugs that Dean Hart hopes will change the world. As I take a seat at a conference table in the offices of NanoGuardian, Hart, the company's chief commercial officer, gets busy setting up a microscope to show me what makes his drugs so special. He removes a small metal canister from the briefcase and pops it open it to reveal a single, plain-looking white tablet, displayed like an engagement ring.

Despite the dramatic presentation, this tablet is not some breakthrough cure. Rather, Hart hopes, it is an answer to one of the world's biggest drug problems: counterfeit and stolen medication. And his solution is right there on the surface. NanoGuardian has invented a way to embed hundreds of pieces of nanosize data—where the drug was made, what pharmacy it was intended for, the dosage and expiration date—on the pill itself.

Counterfeit, stolen and substandard pharmaceuticals are showing up around the world. Recent estimates from the World Health Organization suggest that as many as 30 percent of all drugs in areas of Africa, Asia and Latin America fall under one of these categories. The story is playing out in the U.S., too. For instance, Pew Health Group reports one episode from 2009 in which 129,000 vials of insulin were stolen and a measly 2 percent were recovered. Some of the rest ended up at legitimate pharmacies in Kentucky, Texas and Georgia, and it's doubtful the thieves kept it at safe refrigerated temperatures during the trip.

Drugs simply aren't tracked from end to end. Allan Coukell, director of medical programs at Pew, puts it this way: You can track the route of a birthday gift from the warehouse to your front door, but there's no system to track a shipment of drugs from the factory to the pharmacy. That's particularly troubling because Pew's research found that 80 percent of the active ingredients in U.S. medications are produced abroad. "In the old days, drugs might have moved from a manufacturer in Illinois or Connecticut to a pharmacy and then to a patient," Coukell tells PM. "Today there's a good chance that the drugs originate overseas and pass through a series of wholesalers and intermediates before getting to pharmacies."

That's where NanoGuardian's idea comes in. Back at the Skokie office, Hart hands me his tablet and starts showing off the security features. On its side, what Hart calls the "belly band," there's a minuscule, off-color sliver that's barely noticeable to the naked eye. Hart positions this sliver under the microscope and a perfectly crafted NanoGuardian logo, just 300 microns in diameter, comes into focus. The logo appears engraved into the pill, but Hart says it is "nanoembossed" using a precise combination of heat and pressure. The hulking machine that makes these delicate indentions is the NanoEncryptor, a 10 x 10–foot piece of industrial might that can process 1.5 million pills in an eight-hour shift. At that rate, Hart says, the cost of nano­encryption comes to a penny a pill. The process can be applied to capsules and vial caps as well as tablets.

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But as impressive as the tiny logo appears under the microscope, it's what I can't see that's most important. Hundreds of pieces of encrypted information are placed in and around the logo. These codes, about 200 nanometers (billionths of a meter) in size, contain information that can be as basic as the date the drug was made or as specific as the name of the supervisor who was on shift when the pill was pressed. In most cases the encrypted information will be uniform for each batch of drugs. However, Hart says, the system can stamp unique information on each pill—an approach that might be used for a sting operation, for example. But to see these codes, you'd need a customized scanning electron microscope and NanoGuardian's proprietary decryption software. That is Hart's trade secret. He won't say in what form the information is encrypted—perhaps it's a series of numbers or symbols, or specifically positioned markings—and I'm not allowed to take a peek at this level of encryption.

Later this year, a leading pharma company—again, Hart won't say which—is slated to roll out the first official batch of drugs encrypted by NanoGuardian. Once the shipment goes out, NanoGuardian will use undercover security officers to buy the drug from a sampling of pharmacies across the country. If these secret shoppers find a drug in California, say, that was supposed to go to Iowa, NanoGuardian immediately will tell the drug maker. The encrypted information could provide a wealth of starting points from which to launch an investigation to determine just where in the supply chain the drug was diverted. NanoGuardian will keep its team of security officers in the field as more companies start using the system to encrypt drugs, and Hart says they will be able to inspect a batch from anywhere in the country in 24 hours.

There are other, simpler methods for rooting out fake drugs, from dogs trained to sniff out counterfeit Viagra to American start-up Sproxil's scratch-and-text system, which attaches a unique identification code to each pack of drugs and conceals it under a foil coating, similar to a scratch-off lotto ticket. (Customers text this code to Sproxil's databaseand within seconds get a text back telling them whether the drug is legitimate.) But Hart hopes that NanoGuardian's too-small-to-be-seen encryption becomes the gold standard. "Counterfeiters are too adept at copying anything they can see. You have to really get into high tech to deceive them, and we think we're about as high-tech as you can get at this point in time," he says.

To a public-health expert like Coukell of Pew, being able to authenticate a drug at the dose level is of paramount importance in knowing whether a drug on the shelf is bogus or stolen. Imagine, for example, that half a lot (a "lot" can be thousands of doses) of medication were stolen, and officials tracked down pills bearing the lot's ID number. With just that information, there would be no way to tell if these drugs came from the stolen half. "That, I think, speaks to the importance of having an identifier that's more specific than a lot number," Coukell says.

Counterfeit and stolen drugs severely jeopardize public-health initiatives and needlessly endanger patients. If mystery meds that contain only a fraction of the necessary active ingredient are doled out for conditions such as malaria, patients receive no therapeutic benefit. If thieves decide to swap dosage labels, which has happened before, pharmacies would have no idea what they were dispensing.

"In many parts of the world, the risk of getting counterfeit drugs is astronomical," Coukell says. "The vast majority of what's in U.S. pharmacies and medicine cabinets is not counterfeit and not adulterated. But the very fact that there's fake drugs floating around means we have to take it seriously."

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